Trials Sponsors Conditions Drugs Pricing

Conditions

Cervical Squamous Cell Carcinoma In Situ Vulvar High Grade Squamous Intraepithelial Lesion

Outcome Measures

Primary Outcomes (1)

Pathologic Response
Complete Response (CR) is defined as absence of intraepithelial neoplasia, Partial Response (PR) is defined as a lower grade of dysplasia than present at baseline (for example, grade 3 decreasing to grade 1).
Week 25

Secondary Outcomes (1)

Incidence of Adverse Events of IRX-2 Administration
Up to 30 months

Study Arms (2)

Arm I (IRX-2)

EXPERIMENTAL

Patients receive cyclophosphamide IV on day 1 and IRX-2 via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection.

Drug: CyclophosphamideDrug: IndomethacinBiological: IRX-2Other: Laboratory Biomarker AnalysisDietary Supplement: MultivitaminDrug: OmeprazoleProcedure: Therapeutic Conventional Surgery

Arm II (placebo)

ACTIVE COMPARATOR

Interventions

CyclophosphamideDrug

Given IV

Arm I (IRX-2)Arm II (placebo)

IndomethacinDrug

Given PO

Arm I (IRX-2)Arm II (placebo)

Eligibility Criteria

Age25 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically confirmed squamous CIN 3, or VIN 3 (usual type only)
The subject is either surgically sterile, postmenopausal, or agrees to practice an effective method of birth control as determined by the investigator (to be continued throughout the study period), except that subjects with CIN 3 are not permitted to use a cervical cap or diaphragm for contraception

Sponsors & Collaborators

Brooklyn ImmunoTherapeutics, LLC
Industrycollaborator
National Cancer Institute (NCI)
NIHcollaborator
University of Southern California

Study Sites (2)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

University of Oklahoma Health Sciences Center, Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

CyclophosphamideIndomethacinIRX 2GeritolOmeprazole

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Results Point of Contact

Title: Tali Homsey
Organization: University of Southern California

Study Officials

Lynda Roman, MD
University of Southern California
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

10 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 28, 2017

First Posted

August 30, 2017

Study Start

November 8, 2017

Actual (reported)

You may not qualify if:

For subjects with cervical dysplasia: evidence of atypical glandular cells or adenocarcinoma in situ (ACIS) based on cervical cytology, colposcopy or biopsy
For subjects with either cervical or vulvar squamous dysplasia: evidence of microinvasive squamous carcinoma based on cytology, colposcopy or biopsy
Pregnancy or lactation
Allergy to ciprofloxacin or other quinolones (because ciprofloxacin is used in preparation of IRX-2)
Allergy to indomethacin (a necessary component of the regimen) or to acetylsalicylic acid (aspirin) due to likely allergy cross-reaction
Aldara (imiquimod) for the topical treatment of lower genital tract warts or dysplasia within 3 months of study enrollment
Known to be positive for human immunodeficiency virus-1 (HIV-1) antibody, human immunodeficiency virus-2 (HIV-2) antibody, hepatitis B surface antigen, or hepatitis C virus antibody
Known to have other immunodeficiency diseases, including cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia
Immunotherapy (eg, interferons, tumor necrosis factor, interleukins) or biological response modifiers (granulocyte-macrophage colony-stimulating factor, granulocyte colony-stimulating factor, macrophage colony-stimulating factor) or any investigational drug within 3 months of study enrollment
Concurrent treatment with systemic corticosteroids at a dose of \>= 5 mg/day of prednisone (or equivalent)
Subjects should not take aspirin (except for low-dose aspirin as prescribed for vascular disease) or other non-prescribed, non-steroidal anti-inflammatory agents from randomization to surgery
An infectious process or any other significant illness such as an autoimmune disease or advanced age that in the opinion of the investigator would compromise the subject?s ability to mount an immune response
Impaired hepatic, renal or hematological function, evidenced by:
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin \>= 2 times upper limit of normal (ULN),
Serum creatinine \>= 2 times ULN, or
+4 more criteria

Study Stopped

IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Arm I (IRX-2)

Arm II (placebo)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Documents

Locations

Study Stopped

IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Arm I (IRX-2)

Arm II (placebo)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Documents

Locations